Trial Outcomes & Findings for Lubiprostone for the Treatment of Chronic Idiopathic Constipation (NCT NCT02651155)
NCT ID: NCT02651155
Last Updated: 2018-08-13
Results Overview
A SBM is defined as any bowel movement (BM) that does not occur within 24 hours after rescue medication use (laxative, suppository, or enema). SBM frequency data was collected in a diary. Participants were given a diary to complete at home where they recorded the date and time of each BM.
COMPLETED
PHASE3
204 participants
Week 1
2018-08-13
Participant Flow
Participants took part in the study at 20 investigative sites in Russia from 17 February 2016 to 26 January 2017.
Participants with a diagnosis of chronic idiopathic constipation as determined by the Rome III Diagnostic Criteria for Functional Constipation were enrolled in 1:1 ratio to receive lubiprostone or placebo.
Participant milestones
| Measure |
Placebo
Lubiprostone placebo-matching capsules, orally, twice daily, for up to 4 weeks.
|
Lubiprostone 24 μg
Lubiprostone 24 μg, capsules, orally, twice daily, for up to 4 weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
99
|
105
|
|
Overall Study
COMPLETED
|
93
|
103
|
|
Overall Study
NOT COMPLETED
|
6
|
2
|
Reasons for withdrawal
| Measure |
Placebo
Lubiprostone placebo-matching capsules, orally, twice daily, for up to 4 weeks.
|
Lubiprostone 24 μg
Lubiprostone 24 μg, capsules, orally, twice daily, for up to 4 weeks.
|
|---|---|---|
|
Overall Study
Pretreatment Event/Adverse Event
|
1
|
2
|
|
Overall Study
Voluntary Withdrawal
|
5
|
0
|
Baseline Characteristics
Lubiprostone for the Treatment of Chronic Idiopathic Constipation
Baseline characteristics by cohort
| Measure |
Placebo
n=99 Participants
Lubiprostone placebo-matching capsules, orally, twice daily, for up to 4 weeks.
|
Lubiprostone 24 μg
n=105 Participants
Lubiprostone 24 μg, capsules, orally, twice daily, for up to 4 weeks.
|
Total
n=204 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
49.0 years
n=5 Participants
|
51.1 years
n=7 Participants
|
50.1 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
81 Participants
n=5 Participants
|
90 Participants
n=7 Participants
|
171 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
18 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
99 participants
n=5 Participants
|
102 participants
n=7 Participants
|
201 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Multiracial
|
0 participants
n=5 Participants
|
2 participants
n=7 Participants
|
2 participants
n=5 Participants
|
|
Region of Enrollment
Russia
|
99 participants
n=5 Participants
|
105 participants
n=7 Participants
|
204 participants
n=5 Participants
|
|
Height
|
166.2 cm
STANDARD_DEVIATION 7.16 • n=5 Participants
|
165.1 cm
STANDARD_DEVIATION 7.77 • n=7 Participants
|
165.6 cm
STANDARD_DEVIATION 7.49 • n=5 Participants
|
|
Weight
|
70.08 kg
STANDARD_DEVIATION 14.206 • n=5 Participants
|
68.75 kg
STANDARD_DEVIATION 11.240 • n=7 Participants
|
69.39 kg
STANDARD_DEVIATION 12.751 • n=5 Participants
|
|
Body Mass Index
|
25.265 kg/m^2
STANDARD_DEVIATION 4.2558 • n=5 Participants
|
25.254 kg/m^2
STANDARD_DEVIATION 4.0513 • n=7 Participants
|
25.259 kg/m^2
STANDARD_DEVIATION 4.1415 • n=5 Participants
|
|
Smoking Classification
Participant has never smoked
|
87 participants
n=5 Participants
|
88 participants
n=7 Participants
|
175 participants
n=5 Participants
|
|
Smoking Classification
Participant is a current smoker
|
9 participants
n=5 Participants
|
11 participants
n=7 Participants
|
20 participants
n=5 Participants
|
|
Smoking Classification
Participant is an ex-smoker
|
3 participants
n=5 Participants
|
6 participants
n=7 Participants
|
9 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Week 1Population: FAS included all participants who were randomized to receive study treatment whether or not they received treatment. Missing values were imputed by last observation carried forward (LOCF) method.
A SBM is defined as any bowel movement (BM) that does not occur within 24 hours after rescue medication use (laxative, suppository, or enema). SBM frequency data was collected in a diary. Participants were given a diary to complete at home where they recorded the date and time of each BM.
Outcome measures
| Measure |
Placebo
n=99 Participants
Lubiprostone placebo-matching capsules, orally, twice daily, for up to 4 weeks.
|
Lubiprostone 24 μg
n=105 Participants
Lubiprostone 24 μg, capsules, orally, twice daily, for up to 4 weeks.
|
|---|---|---|
|
Spontaneous Bowel Movement (SBM) Frequency at Week 1
|
3.6 SBMs/week
Standard Deviation 2.51
|
5.0 SBMs/week
Standard Deviation 2.94
|
SECONDARY outcome
Timeframe: Weeks 2, 3 and 4Population: FAS included all participants who were randomized to receive study treatment whether or not they received treatment. Missing values were imputed by LOCF method.
A SBM is defined as any BM that does not occur within 24 hours after rescue medication use. SBM frequency data was collected in a diary. Participants were given a diary to complete at home where they recorded the date and time of each BM.
Outcome measures
| Measure |
Placebo
n=99 Participants
Lubiprostone placebo-matching capsules, orally, twice daily, for up to 4 weeks.
|
Lubiprostone 24 μg
n=105 Participants
Lubiprostone 24 μg, capsules, orally, twice daily, for up to 4 weeks.
|
|---|---|---|
|
SBM Frequency at Weeks 2, 3 and 4
Week 2
|
3.9 SBMs/week
Standard Deviation 2.52
|
5.0 SBMs/week
Standard Deviation 2.82
|
|
SBM Frequency at Weeks 2, 3 and 4
Week 3
|
3.8 SBMs/week
Standard Deviation 2.87
|
5.1 SBMs/week
Standard Deviation 2.72
|
|
SBM Frequency at Weeks 2, 3 and 4
Week 4
|
3.7 SBMs/week
Standard Deviation 2.72
|
5.2 SBMs/week
Standard Deviation 2.61
|
SECONDARY outcome
Timeframe: Up to 24 hours after the first dose of study medicationPopulation: FAS included all participants who were randomized to receive study treatment whether or not they received treatment.
A SBM is defined as any BM that does not occur within 24 hours after rescue medication use. Percentage of participants who had a SBM within 24 hours after the first dose was assessed and derived from the data on SBMs collected in the participant diary.
Outcome measures
| Measure |
Placebo
n=99 Participants
Lubiprostone placebo-matching capsules, orally, twice daily, for up to 4 weeks.
|
Lubiprostone 24 μg
n=105 Participants
Lubiprostone 24 μg, capsules, orally, twice daily, for up to 4 weeks.
|
|---|---|---|
|
Percentage of Participants Who Had a SBM Within 24 Hours After the First Dose of Study Medication
|
35.4 percentage of participants
|
46.7 percentage of participants
|
SECONDARY outcome
Timeframe: Weeks 1, 2, 3 and 4Population: FAS included all participants who were randomized to receive study treatment whether or not they received treatment. Missing values were imputed by LOCF method.
For each participant, the mean degree of straining was averaged for all SBMs in a given week. The degree of straining for each SBM was collected in the participant diary. The degree of straining is scored on a 5-point scale where: 0=No straining, 1=Mild straining, 2=Moderate straining, 3=Strong straining or 4=Very strong straining with higher scores indicating more severe straining.
Outcome measures
| Measure |
Placebo
n=99 Participants
Lubiprostone placebo-matching capsules, orally, twice daily, for up to 4 weeks.
|
Lubiprostone 24 μg
n=105 Participants
Lubiprostone 24 μg, capsules, orally, twice daily, for up to 4 weeks.
|
|---|---|---|
|
Mean Degree of Straining Score
Week 1
|
2.3 scores on a scale
Standard Deviation 1.09
|
1.7 scores on a scale
Standard Deviation 1.01
|
|
Mean Degree of Straining Score
Week 2
|
2.0 scores on a scale
Standard Deviation 1.11
|
1.6 scores on a scale
Standard Deviation 1.04
|
|
Mean Degree of Straining Score
Week 3
|
1.9 scores on a scale
Standard Deviation 1.19
|
1.4 scores on a scale
Standard Deviation 0.99
|
|
Mean Degree of Straining Score
Week 4
|
2.0 scores on a scale
Standard Deviation 1.19
|
1.3 scores on a scale
Standard Deviation 1.00
|
SECONDARY outcome
Timeframe: Weeks 1, 2, 3 and 4Population: FAS included all participants who were randomized to receive study treatment whether or not they received treatment. Missing values were imputed by LOCF method.
For each participant, the mean stool consistency score was averaged for all SBMs in a given week. The mean degree of stool consistency for each SBM was collected in the participant diary based on the Bristol Stool Chart. The Bristol Stool Chart is a visual medical aid designed to classify the form of human feces into seven categories where: 1=Hard and round (difficult-to-pass), 2=Sausage-shaped but hard stool, 3=Sausage-shaped stool with cracks on the surface, 4=Sausage-shaped, soft stool with smooth surface, or coiled stool, 5=Soft, half-solid (and easy-to-pass) stool with clear crease, 6=Unshaped, loose stool with small, irregular-shaped pieces, or mushy stool or 7=Watery stool without solid pieces (entirely liquid).
Outcome measures
| Measure |
Placebo
n=99 Participants
Lubiprostone placebo-matching capsules, orally, twice daily, for up to 4 weeks.
|
Lubiprostone 24 μg
n=105 Participants
Lubiprostone 24 μg, capsules, orally, twice daily, for up to 4 weeks.
|
|---|---|---|
|
Mean Degree Stool Consistency Score
Week 1
|
3.0 scores on a scale
Standard Deviation 1.10
|
3.6 scores on a scale
Standard Deviation 1.37
|
|
Mean Degree Stool Consistency Score
Week 2
|
3.3 scores on a scale
Standard Deviation 1.08
|
3.7 scores on a scale
Standard Deviation 1.33
|
|
Mean Degree Stool Consistency Score
Week 3
|
3.2 scores on a scale
Standard Deviation 1.11
|
3.8 scores on a scale
Standard Deviation 1.28
|
|
Mean Degree Stool Consistency Score
Week 4
|
3.0 scores on a scale
Standard Deviation 1.06
|
3.8 scores on a scale
Standard Deviation 1.30
|
SECONDARY outcome
Timeframe: Weeks 1, 2, 3 and 4Population: FAS included all participants who were randomized to receive study treatment whether or not they received treatment. Missing values were imputed by LOCF method.
The abdominal symptoms (bloating and discomfort upon waking in the morning) were scored weekly on a 5-point scale, where: 0=None, 1=Mild, 2=Moderate, 3=Severe or 4=Very severe, with a higher score indicating more severe symptoms. Assessment of weekly abdominal symptoms were recorded by the participant in the diary.
Outcome measures
| Measure |
Placebo
n=99 Participants
Lubiprostone placebo-matching capsules, orally, twice daily, for up to 4 weeks.
|
Lubiprostone 24 μg
n=105 Participants
Lubiprostone 24 μg, capsules, orally, twice daily, for up to 4 weeks.
|
|---|---|---|
|
Weekly Abdominal Symptoms Score
Abdominal Bloating, Week 1
|
1.6 scores on a sclae
Standard Deviation 1.00
|
1.5 scores on a sclae
Standard Deviation 0.86
|
|
Weekly Abdominal Symptoms Score
Abdominal Bloating, Week 2
|
1.5 scores on a sclae
Standard Deviation 1.04
|
1.3 scores on a sclae
Standard Deviation 0.94
|
|
Weekly Abdominal Symptoms Score
Abdominal Bloating, Week 3
|
1.6 scores on a sclae
Standard Deviation 1.02
|
1.2 scores on a sclae
Standard Deviation 1.01
|
|
Weekly Abdominal Symptoms Score
Abdominal Bloating, Week 4
|
1.4 scores on a sclae
Standard Deviation 1.03
|
1.1 scores on a sclae
Standard Deviation 0.93
|
|
Weekly Abdominal Symptoms Score
Abdominal Discomfort, Week 1
|
1.7 scores on a sclae
Standard Deviation 0.98
|
1.5 scores on a sclae
Standard Deviation 0.95
|
|
Weekly Abdominal Symptoms Score
Abdominal Discomfort, Week 2
|
1.6 scores on a sclae
Standard Deviation 1.07
|
1.3 scores on a sclae
Standard Deviation 0.98
|
|
Weekly Abdominal Symptoms Score
Abdominal Discomfort, Week 3
|
1.6 scores on a sclae
Standard Deviation 1.06
|
1.2 scores on a sclae
Standard Deviation 1.01
|
|
Weekly Abdominal Symptoms Score
Abdominal Discomfort, Week 4
|
1.5 scores on a sclae
Standard Deviation 1.02
|
1.2 scores on a sclae
Standard Deviation 0.97
|
Adverse Events
Placebo
Lubiprostone 24 μg
Serious adverse events
| Measure |
Placebo
n=99 participants at risk
Lubiprostone placebo-matching capsules, orally, twice daily, for up to 4 weeks.
|
Lubiprostone 24 μg
n=105 participants at risk
Lubiprostone 24 μg, capsules, orally, twice daily, for up to 4 weeks.
|
|---|---|---|
|
Nervous system disorders
Haemorrhagic stroke
|
1.0%
1/99 • Baseline and up to Week 6
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/105 • Baseline and up to Week 6
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
Other adverse events
| Measure |
Placebo
n=99 participants at risk
Lubiprostone placebo-matching capsules, orally, twice daily, for up to 4 weeks.
|
Lubiprostone 24 μg
n=105 participants at risk
Lubiprostone 24 μg, capsules, orally, twice daily, for up to 4 weeks.
|
|---|---|---|
|
Gastrointestinal disorders
Nausea
|
3.0%
3/99 • Baseline and up to Week 6
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
10.5%
11/105 • Baseline and up to Week 6
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Diarrhoea
|
3.0%
3/99 • Baseline and up to Week 6
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
7.6%
8/105 • Baseline and up to Week 6
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The first study related publication will be a multi-center publication submitted within 24 months after conclusion or termination of a study at all sites. After such multi site publication, all proposed site publications and presentations will be submitted to sponsor for review 60 days in advance of publication. Site will remove Sponsor confidential information unrelated to study results. Sponsor can delay a proposed publication for another 60 days to preserve intellectual property.
- Publication restrictions are in place
Restriction type: OTHER